Randomized Double Blind Placebo Control Study in Patients With Schizophrenia (ROSES)
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Purpose
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. Social dysfunction has major economic consequences in both the developed and developing world. There is evidence that anti-inflammatory treatment may have beneficial effects in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Psychosis Not Otherwise Specified Schizophreniform Disorder |
Drug: Ondanstron Drug: Simvastatin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Double Blind Placebo Controlled Study of Ondansetron and Simvastatis Added to Treatment as Usual in Patients With Schizophrenia |
- Negative symptom severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Negative symptom severity as defined by negative syndrome subscale score on the Positive and Negative Syndrome Scale
- cognitive functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Full PANSS and positive syndrome subscale score
- Clinical Global Impression
- Functional outcome
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ondansetron |
Drug: Ondanstron
ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
|
| Active Comparator: Simvastatin |
Drug: Simvastatin
Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo added to TAU
|
Detailed Description:
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Evidence indicates that anti-inflammatory treatment may have beneficial effects in schizophrenia. From our preliminary randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil, it is indicated that addition of minocycline (an antibiotic and anti-inflammatory drug) for one year to treatment as usual (TAU) reduced negative symptoms and improved some cognitive measures (Chaudhry et al 2009).
Statins are primarily HMG-CoA reductase inhibitors also anti-inflammatory agents and known to decrease C-reactive protein (CRP). Higher levels of CRP (>0.50 mg/dl) are associated with marked negative symptoms and higher total PANSS scores in patients with schizophrenia. (Fan et al 2007)
Ondansetron, a selective 5-hydroxytryptamine-3 antagonist, is quite commonly used as an antiemetic in cancer patients (Marty et al 1990). There are several small trials suggesting that ondansetron as an adjunct to antipsychotics is effective in improving negative symptoms and memory in patients suffering from schizophrenia (Ahkonzadeh et al 2009, Levkovitz et al 2005 and Zhang et al 2006).
The Primary objective of this study is addition of ondansetron and /or simvastatin to TAU for patients with schizophrenia will result in improvement in negative symptoms
The Secondary objectives include:
- improvement in positive or other symptoms
- social functioning
- cognitive functions
- additive effects of ondansetron and simvastatin
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Patients aged 18 to 65 years
- Patients will be recruited both from inpatients and outpatients.
- Diagnostic and Statistical Manual-IV (DSM-IV TR) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
- Competent and willing to give informed consent
- Stable on medication 4 weeks prior to baseline
- No planned medication change
- Able to take oral medication and likely to complete the required evaluations
- Female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication,
- Not planning to relocate in the next 12 months
Exclusion Criteria
- Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
- Subjects who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
- Any change of psychotropic medications within the previous 4 weeks
- Pregnant or lactating women and those of reproductive age without adequate contraception
Contacts and Locations| Contact: Imran Chaudhry, MD | +441254226392 | imran.chaudhry@manchester.ac.uk |
| Contact: Nusrat Husain, MD | +441254226392 | nusrat.husain@manchester.ac.uk |
| Pakistan | |
| Abbasi Shaheed Hospital | Recruiting |
| Karachi, Sindh, Pakistan | |
| Contact: Dr. Muinir Hamirani, FCPS +923009272002 mmham@yahoo.com | |
| Dow university of Health Sciences | Recruiting |
| Karachi, Sind, Pakistan | |
| Contact: Razaur Rehman, FCPS +923002579364 razaur@yahoo.com | |
| Karwan e hayat | Recruiting |
| Karachi, Pakistan | |
| Contact: Ajmal Kazmi, MRCPsych +923213783890 kazmiajmal@yahoo.com | |
| Principal Investigator: | Imran Chaudhry, MD | University of Manchester |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01602029 History of Changes |
| Other Study ID Numbers: | roses_pill |
| Study First Received: | May 17, 2012 |
| Last Updated: | May 17, 2012 |
| Health Authority: | Pakistan: Research Ethics Committee |
Keywords provided by Pakistan Institute of Learning and Living:
|
Anti inflammatory Schizophrenia Simvastatin Ondansetron |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Ondansetron Simvastatin Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipruritics |
Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
ClinicalTrials.gov processed this record on May 16, 2013